Methods

A payment per switched patient was negotiated with commissioners for reinvestment into the inflammatory bowel disease (IBD) service. Information was sent to each patient offering counseling with the pharmacist. Over 8 weeks all patients were switched from Remicade® to Remsima®, IFX trough levels and antibodies, C-reactive protein (CRP), Harvey Bradshaw (HB) or simple clinical colitis activity score (SCCAI) and faecal calprotectin (FCLP) were recorded prior to the infusion of the first dose of biosimilar. 6 month later HB or SCCAI, CRP and FCLP were remeasured and compared.

The pharmacist reviewed all results and managed any therapy changes, if necessary with multidisciplinary team (MDT) review. Savings were recorded.

Results

A payment of £1250/patient was negotiated to fund the switch. 71 (60 CD, 11 UC)patients were switched realising an income of £88,750 used to fund a specialist IBD nurse.

No patient requested an additional appointment due to the pharmacist conducting counselling during infusion clinics prior to the switch. 17 patients stopped IFX, 7 due to antibodies and 2 due to loss of response (LOR) and need for surgery, 8 patients were changed to alternatives by MDT review.

54 patients continued on IFX infusions without experiencing LOR in the following 6 months. Savings on drugs was £224,000 and overall £300,000.

CRP and IBD scores were reviewed at each infusion. A minority of patients submitted FCLP pre and post preventing meaningful anlysis.

Table 2. Patients clinical parameter pre and post switch

Crohn's disease (N=60)

Ulcerative colitis (N=11)

No. (%) of pts with IBD score changes of ≤1

28 (52%)

6 (60%)

No. (%) of pts with IBD score reduction ≥2

11 (20%)

1 (10%)

No. (%) of pts with IBD score raise ≥2

14 (26%)

3 (30%)

No. (%) of pts with IFX antibodies

5 (8%)

2 (18%)

No. (%) of pts IFX levles below ≤1.9

15 (25%)

2 (18%)

No. (%) of pts IFX levels ≥8.1

5 (8%)

4 (36%)

No. (%) of pts with CRP change of ≤5 pre switch

43 (71%)

9 (81%)

No. (%) of pts with CRP ≤5 post switch

44 (73%)

9 (81%)

FCLP sumitted pre/post / pre&post

38 (63%)/12 (20%) / 8 (14%)

6 (55%)/2 (18%) / 1 (9%)

Conclusion

Switching to biosimilar IFX is safe.

Active management of treatment around the switch by the Specialist IBD pharmacist saves money, realises investment into the service, optimises therapy in a timely manner and reduces outpatient appointments.

IBD pharmacists are failiar with TDM, management of IBD patients and able to negotiate with commissioners directly.